A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I)

A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I) - A patch test of KP-103 following single and repeated application(Phase I)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001674

Enrollment

Registered

2009-01-30

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nail fungal infection

Interventions

To apply 0.2mL of KP-103 1% to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days To apply 0.2mL of KP-103 5% to the patch test unit, and apply the patch to

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) healthy adult male (2) Age: between 20 and 65 years old (3) The subject without dermal disease of dermatitis or eczema etc. (4) The subject without medical history of the rash to the adhesive plaster, contact dermatitis to metal, cosmetic and household articles, or anaphylaxis to light (5) BMI: between 18.5 and 25.0 (round off the number to one decimal place) (6) Regarding screening examinations the results of each examined parameter must be within the standard reference range. However should a parameter deviate from the standard range and the investigator or sub investigator judge that the grade of severity is within the normal range of physiological variation and does not present a problem to the subject's safety, inclusion is also allowable.

Exclusion criteria

Exclusion criteria: (1) The subject with medical history of liver, renal, cardiac or hematologic disease corresponding over grade 2 of "Severity Criteria for Drug Adverse Reaction" (2) The subject with medical history of allergy to drug, or idiosyncrasy (alcohol hypersensitivity etc.) (3) The subject having been using medications regularly (4) The subject with experience of drug dependence (narcotic drug, stimulant and psychotropic drug etc), or alcoholism (5) The subject having used medications or the subject with the possibility of using medications within 1 week prior to the initiation of the investigational product administration (6) The subject having took blood drawing over 400mL within 12 weeks prior, or over 200mL within 4 weeks prior, or having took ingredient blood donation within 2 weeks prior to the initiation of the investigational product administration (7) The subject with participation in clinical trial within 16 weeks prior to the initiation of the intvesitigational product administration (8) The subject having been proved to be positive from the result of immunological tests (HBs antigen, HCV antibody, test for syphilis, HIV antigen and antibody) (9) The subject having been judged to be ineligible for the participation in this study by the investigator or sub investigator for any other reason

Design outcomes

Primary

Measure	Time frame
Assessment of skin irritancy, Assessment of photosensitization, KP-103 and KP-103 metabolite concentration in the blood plasma	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026